Malignant GliomaNCT03915912
Mindfulness Meditation in Glioma Patients
A study testing Mindfulness meditation in people with Malignant Glioma, run by Duke University at 1 site in United States.
Trial summary
This pilot study is designed to determine the feasibility of providing a mindfulness meditation program to patients with newly diagnosed malignant glioma during standard of care chemoradiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Glioma
- What is being tested?
- Mindfulness meditation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Apr 2019to 9 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 18 years of age
- NCCN distress scale ≥ 4 OR at least one of the following problems indicated on the NCCN distress thermometer worksheet: depression, fears, nervousness, sadness, worry, loss of interest in usual activities, sleep, memory, or fatigue
- Karnofsky Performance Status (KPS) ≥ 70
- Patient must have histologically confirmed, newly diagnosed WHO grade III or IV malignant glioma
- Patient must be prior to a planned 6-week standard of care chemoradiation regimen
- Patient can speak, read, and write English
- Patient has access to a telephone for mindfulness training
- Patient has access to internet
Who cannot join
- Patients previously or currently practicing or participating in mindfulness meditation practice
- Intermittent or active psychosis
- Psychiatric hospitalization within the last 6 months
- Hospitalized in a rehab facility within the last 6 months for substance abuse
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
Official title: A Feasibility Study of Mindfulness Meditation Practice in Malignant Glioma Patients Throughout Standard of Care Chemoradiation
This pilot study is designed to determine the feasibility of providing a mindfulness meditation program to patients with newly diagnosed malignant glioma during standard of care chemoradiation. Newly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session. Patients will complete various Quality of Life questionnaires and distress measuring tools prior to initiating the mindfulness sessions, at the clinic visit following the mindfulness intervention, and ~2 months after completing the mindfulness intervention. Additionally, patients will be provided with supplemental materials including website references and guided audiotape meditations to guide their individual practice outside of the weekly guided sessions.
The main objective of this study is to assess the feasibility of a mindfulness meditation intervention program, designed to mitigate the distress associated with the disease and first line treatment of patients with malignant glioma, and to determine whether it merits additional research in a subsequent trial.
There are no risks associated with participation in this study.
Read the detailed description
Fifteen newly diagnosed WHO grade III or IV malignant glioma patients will be enrolled to this pilot feasibility study. Following completion of informed consent, patients will complete a baseline assessment consisting of various QoL/distress assessments including the Trail Making Test, the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), the Pittsburgh Sleep Quality Index (PSQI), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy-Brain (FACT-Br), the Five Facet Mindfulness Questionnaire - short form (FFMQ-SF), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp12), the NCCN Distress Thermometer with Symptom Inventory, and the Hospital Anxiety and Depression Scale (HADS). They will then begin the mindfulness intervention, consisting of six weekly telephone-based mindfulness sessions followed by one in-person mindfulness session. Post-treatment measures and an Exit Survey will be administered following the one in-person mindfulness session. Two months later, the QoL, cognition and distress assessments will be repeated and a Final Exit Survey will be administered. The Exit Survey will ask the patient about their individual mindfulness practice during the intervention, their intention to continue the practice beyond participation in this study, their satisfaction with the services received, and their perception of the effectiveness of the program. The Final Exit Survey will ask the patient about their mindfulness practice since the Exit Survey, and their intention to continue with the mindfulness practice. The investigators will also collect demographic data such as age, marital status, education, employment, date of diagnosis and death, tumor grade, histology, and type of treatment from the patient.
- Conditions
- Malignant Glioma
- Being tested
- Mindfulness meditation
- Keywords
- Malignant Glioma, Mindfulness, Dina Randazzo, Meditation, Katherine Barnett Peters
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness meditationBehavioural
The study intervention consists of seven mindfulness sessions (six 1-hour telephone sessions and one 1-hour in-person session). The six weekly telephone-based mindfulness sessions will occur in a one-on-one format and will be followed by one in-person, one-on-one session, which will occur at the post-chemoradiation standard of care clinic visit.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness meditation | Experimental | Newly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session. Patients will complete various Quality of Life questionnaires and distress measuring tools prior to initiating the mindfulness sessions, at the clinic visit following the mindfulness intervention, and ~2 months after completing the mindfulness intervention. Additionally, patients will be provided with supplemental materials including website references and guided audiotape meditations to guide their individual practice outside of the weekly guided sessions. Receives: Behavioral: Mindfulness meditation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability: Number of sessions that the patient attends
One measure of the acceptability of the mindfulness intervention is the number of sessions the patient attended. The number of patients who attend at least 3 of the 6 telephone-based mindfulness session in addition to the in-person session is reported.
Measured: 6 weeks
Acceptability: Patients' satisfaction with the mindfulness sessions: The number of patients that respond either 'somewhat satisfied,' 'mostly satisfied,' or 'very satisfied' to the question 'How satisfied are you with the mindfulness sessions?'
One measure of the acceptability of the mindfulness intervention is the extent of satisfaction patients have with the mindfulness sessions. The number of patients that respond either 'somewhat satisfied,' 'mostly satisfied,' or 'very satisfied' to the question 'How satisfied are you with the mindfulness sessions?' on the exit survey is reported.
Measured: 6 weeks
Acceptability: Percentage of patients who intend to continue meditation after study completion
One measure of the acceptability of the mindfulness intervention is the intent to continue practicing mindfulness meditation following study completion. The percentage of patients who respond 'yes' to the question 'Do you plan on continuing to practice mindfulness meditation?' on the 6-week exit survey is reported.
Measured: 6 weeks
Acceptability: Percentage of patients who continued meditation practice during the 2 months after study completion
One measure of the acceptability of the mindfulness intervention is the percentage of patients that continued mindfulness meditation during the 2 months following the intervention as measured by question 'Did you continue your meditation practice after the training sessions?' captured on the final exit survey given 4 months after study initiation, which is 2 months after completing the mindfulness intervention. The percentage of patients responding 'yes' to this question is reported.
Measured: 4 months
Demand: Total time required to enroll 15 patients
One measure of the demand of the mindfulness intervention is the length of time required to enroll 15 patients. The length of time in months needed to enroll 15 patients is reported.
Measured: 2 years
Demand: Percentage of patients who enroll in the study
One measure of the demand of the mindfulness intervention is the percentage of patients enrolling in the study of those to which the study is offered. This percentage is reported.
Measured: 2 years
Implementation: Percentage of patients who complete the study questionnaires
Implementation of the mindfulness intervention is measured by the percentage of patients who complete the study questionnaires measuring quality of life and evaluation of the mindfulness intervention at each time point of the study. Questionnaires are completed at baseline during screening, approximately 6 weeks post-baseline at the in-person mindfulness session, and 4 months post-baseline at the follow-up final exit survey. The percentage of patients who completed all questionnaires at each study time point is reported.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start11 Apr 2019
- Primary completion9 Jan 2020
- Study completion9 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant GliomaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Newly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session.
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Duke Cancer Institute
- Responsible party
- Sponsor
- Investigators
- Katherine B Peters, MD, PhD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03915912
- Sponsor's protocol ID
- Pro00101218
- Status last verified
- Jun 2023
- First submitted
- 12 Apr 2019
- Last updated
- 7 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Mindfulness Meditation Practice in Malignant Glioma Patients Throughout Standard of Care Chemoradiation
- ClinicalTrials.gov ID
- NCT03915912
- Acronym / sponsor ID
- Pro00101218
- Conditions
- Malignant Glioma
- Keywords
- Malignant Glioma, Mindfulness, Dina Randazzo, Meditation, Katherine Barnett Peters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Duke Cancer Institute
- Study start
- 11 Apr 2019 (actual)
- Primary completion
- 9 Jan 2020 (actual)
- Study completion
- 9 Jan 2020 (actual)
- First posted
- 16 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pilot study is designed to determine the feasibility of providing a mindfulness meditation program to patients with newly diagnosed malignant glioma during standard of care chemoradiation. Newly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session. Patients will complete various Quality of Life questionnaires and distress measuring tools prior to initiating the mindfulness sessions, at the clinic visit following the mindfulness intervention, and ~2 months after completing the mindfulness intervention. Additionally, patients will be provided with supplemental materials including website references and guided audiotape meditations to guide their individual practice outside of the weekly guided sessions.
The main objective of this study is to assess the feasibility of a mindfulness meditation intervention program, designed to mitigate the distress associated with the disease and first line treatment of patients with malignant glioma, and to determine whether it merits additional research in a subsequent trial.
There are no risks associated with participation in this study.
Detailed description
Fifteen newly diagnosed WHO grade III or IV malignant glioma patients will be enrolled to this pilot feasibility study. Following completion of informed consent, patients will complete a baseline assessment consisting of various QoL/distress assessments including the Trail Making Test, the Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog), the Pittsburgh Sleep Quality Index (PSQI), the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F), the Functional Assessment of Cancer Therapy-Brain (FACT-Br), the Five Facet Mindfulness Questionnaire - short form (FFMQ-SF), the Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being (FACIT-Sp12), the NCCN Distress Thermometer with Symptom Inventory, and the Hospital Anxiety and Depression Scale (HADS). They will then begin the mindfulness intervention, consisting of six weekly telephone-based mindfulness sessions followed by one in-person mindfulness session. Post-treatment measures and an Exit Survey will be administered following the one in-person mindfulness session. Two months later, the QoL, cognition and distress assessments will be repeated and a Final Exit Survey will be administered. The Exit Survey will ask the patient about their individual mindfulness practice during the intervention, their intention to continue the practice beyond participation in this study, their satisfaction with the services received, and their perception of the effectiveness of the program. The Final Exit Survey will ask the patient about their mindfulness practice since the Exit Survey, and their intention to continue with the mindfulness practice. The investigators will also collect demographic data such as age, marital status, education, employment, date of diagnosis and death, tumor grade, histology, and type of treatment from the patient.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Newly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness meditation | Experimental | Behavioral: Mindfulness meditationNewly diagnosed malignant glioma patients will participate in six 1-hour mindfulness sessions over the phone, followed by one 1-hour in-person mindfulness session. Patients will complete various Quality of Life questionnaires and distress measuring tools prior to initiating the mindfulness sessions, at the clinic visit following the mindfulness intervention, and ~2 months after completing the mindfulness intervention. Additionally, patients will be provided with supplemental materials including website references and guided audiotape meditations to guide their individual practice outside of the weekly guided sessions. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years of age
- NCCN distress scale ≥ 4 OR at least one of the following problems indicated on the NCCN distress thermometer worksheet: depression, fears, nervousness, sadness, worry, loss of interest in usual activities, sleep, memory, or fatigue
- Karnofsky Performance Status (KPS) ≥ 70
- Patient must have histologically confirmed, newly diagnosed WHO grade III or IV malignant glioma
- Patient must be prior to a planned 6-week standard of care chemoradiation regimen
Key exclusion criteria (4 listed)
- Patients previously or currently practicing or participating in mindfulness meditation practice
- Intermittent or active psychosis
- Psychiatric hospitalization within the last 6 months
- Hospitalized in a rehab facility within the last 6 months for substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness meditationThe study intervention consists of seven mindfulness sessions (six 1-hour telephone sessions and one 1-hour in-person session). The six weekly telephone-based mindfulness sessions will occur in a one-on-one format and will be followed by one in-person, one-on-one session, which will occur at the post-chemoradiation standard of care clinic visit. | Behavioural | Mindfulness meditation |
Primary outcome
Acceptability: Number of sessions that the patient attends
Time frame: 6 weeks
One measure of the acceptability of the mindfulness intervention is the number of sessions the patient attended. The number of patients who attend at least 3 of the 6 telephone-based mindfulness session in addition to the in-person session is reported.
Acceptability: Patients' satisfaction with the mindfulness sessions: The number of patients that respond either 'somewhat satisfied,' 'mostly satisfied,' or 'very satisfied' to the question 'How satisfied are you with the mindfulness sessions?'
Time frame: 6 weeks
One measure of the acceptability of the mindfulness intervention is the extent of satisfaction patients have with the mindfulness sessions. The number of patients that respond either 'somewhat satisfied,' 'mostly satisfied,' or 'very satisfied' to the question 'How satisfied are you with the mindfulness sessions?' on the exit survey is reported.
Acceptability: Percentage of patients who intend to continue meditation after study completion
Time frame: 6 weeks
One measure of the acceptability of the mindfulness intervention is the intent to continue practicing mindfulness meditation following study completion. The percentage of patients who respond 'yes' to the question 'Do you plan on continuing to practice mindfulness meditation?' on the 6-week exit survey is reported.
Acceptability: Percentage of patients who continued meditation practice during the 2 months after study completion
Time frame: 4 months
One measure of the acceptability of the mindfulness intervention is the percentage of patients that continued mindfulness meditation during the 2 months following the intervention as measured by question 'Did you continue your meditation practice after the training sessions?' captured on the final exit survey given 4 months after study initiation, which is 2 months after completing the mindfulness intervention. The percentage of patients responding 'yes' to this question is reported.
Demand: Total time required to enroll 15 patients
Time frame: 2 years
One measure of the demand of the mindfulness intervention is the length of time required to enroll 15 patients. The length of time in months needed to enroll 15 patients is reported.
Demand: Percentage of patients who enroll in the study
Time frame: 2 years
One measure of the demand of the mindfulness intervention is the percentage of patients enrolling in the study of those to which the study is offered. This percentage is reported.
Implementation: Percentage of patients who complete the study questionnaires
Time frame: 4 months
Implementation of the mindfulness intervention is measured by the percentage of patients who complete the study questionnaires measuring quality of life and evaluation of the mindfulness intervention at each time point of the study. Questionnaires are completed at baseline during screening, approximately 6 weeks post-baseline at the in-person mindfulness session, and 4 months post-baseline at the follow-up final exit survey. The percentage of patients who completed all questionnaires at each study time point is reported.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
- The Preston Robert Tisch Brain Tumor Center at DukeLink provided by the sponsor.
- Duke Cancer InstituteLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katherine B Peters, MD, PhD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness meditation in people with Malignant Glioma, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability: Number of sessions that the patient attends (time frame: 6 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.